510(k) · Cleared
ClearedSynthes Spine Occipital-Cervical Plate/Rod and Hook System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Synthes (Usa) · KWP Appliance, Fixation, Spinal Interlaminal
Cleared on Nov 25, 1998 as substantially equivalent to K965221 (Surgicraft, Ltd., 1997) after a 146-day review. Its family tree reaches back 2 generations to 1985. 2 of the 695 devices in its family, counting itself, have a Class I recall. 692 later devices descend from it.
- Decided
- Nov 25, 1998
- Review
- 146 days
- Class
- Class II
- Product code
- KWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K853033 (1985). 692 later devices descend from it, 4 citing it directly. 2 of the 695 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK853033 Hartshill Rect & Wires, Spinal Fixation SystemA.W. Showell (Surgicraft), Ltd. · 1985
- 1 generation backK965221 Ransford Cervical Fixation SystemSurgicraft, Ltd. · 1997
- This deviceK982322 Synthes Spine Occipital-Cervical Plate/Rod and Hook SystemSynthes (Usa) · 1998
- Descendant · cites it directly · 671 of its ownK002733 Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000
- Descendant · 2 generations on · 660 of its ownK013222 Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001
- Descendant · 2 generations on · 659 of its ownK022190 Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002
- Descendant · 2 generations on · 658 of its ownK030103 Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003
- Descendant · 2 generations on · 657 of its ownK041203 Summit Oct Spinal SystemDepuy Spine, Inc. · 2004
Showing 5 of 692 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 692 · See all- K002733Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2000 · cites it directly671descendants
- K013222Summit Occipito-Cervico- Thoracic (Oct) Spinal SystemDepuyacromed · 2001 · 2 generations on660descendants
- K022190Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal SystemDepuyacromed · 2002 · 2 generations on659descendants
- K030103Summit Oct Spinal System Minipolyaxial ScrewsDepuyacromed · 2003 · 2 generations on658descendants
- K041203Summit Oct Spinal SystemDepuy Spine, Inc. · 2004 · 2 generations on657descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K853033 | Hartshill Rect & Wires, Spinal Fixation System | A.W. Showell (Surgicraft), Ltd. | 1985 | — |
| −1 | K965221 | Ransford Cervical Fixation System | Surgicraft, Ltd. | 1997 | — |
| 0 (this device) | K982322 | Synthes Spine Occipital-Cervical Plate/Rod and Hook System | Synthes (Usa) | 1998 | — |
| +1 | K002733 | Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2000 | — |
| +2 | K013222 | Summit Occipito-Cervico- Thoracic (Oct) Spinal System | Depuyacromed | 2001 | — |
| +2 | K022190 | Modification to Summit Occipito-Cervico-Thoracic (Oct) Spinal System | Depuyacromed | 2002 | — |
| +2 | K030103 | Summit Oct Spinal System Minipolyaxial Screws | Depuyacromed | 2003 | — |
| +2 | K041203 | Summit Oct Spinal System | Depuy Spine, Inc. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 5 | 0 |
| 2006 | 6 | 0 |
| 2007 | 10 | 0 |
| 2008 | 15 | 0 |
| 2009 | 13 | 0 |
| 2010 | 13 | 1 |
| 2011 | 16 | 0 |
| 2012 | 29 | 0 |
| 2013 | 32 | 0 |
| 2014 | 32 | 0 |
| 2015 | 38 | 0 |
| 2016 | 29 | 0 |
| 2017 | 38 | 0 |
| 2018 | 39 | 0 |
| 2019 | 32 | 0 |
| 2020 | 39 | 0 |
| 2021 | 33 | 1 |
| 2022 | 38 | 0 |
| 2023 | 67 | 0 |
| 2024 | 57 | 0 |
| 2025 | 52 | 0 |
| 2026 | 50 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
2 devices in this family have a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K965221 | Ransford Cervical Fixation System Our OCR of the scanned summary read K965227, FDA’s number for Osom Classic HCG-Urine Test (115) (Wyntek Diagnostics, Inc.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Ransford Cervical Fixation System”. | 1997 |
What descends from it? (692)
See all 6924 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 13 years and passes through 3 companies; a new generation was cleared every 11.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K002733 (Depuyacromed, 2000) has gone furthest, with 671 descendants of its own.
- 2 other devices also cite its predicate K965221.
How does its category compare?
All KWP devicesKWP Appliance, Fixation, Spinal Interlaminal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KWP
9in 2015
2026 to Oct 25, outlined.
Median 510(k) review, days · KWP
113in 2015
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KWP
2in 2022
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KWP
494in 2025
MAUDE reports naming product code KWP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 14 | 96 | 2 | 210 |
| 2008 | 13 | 50 | 1 | 594 |
| 2009 | 12 | 89 | 23 | 682 |
| 2010 | 14 | 186 | 2 | 474 |
| 2011 | 12 | 67 | 6 | 792 |
| 2012 | 18 | 112 | 1 | 918 |
| 2013 | 12 | 99 | 3 | 1,090 |
| 2014 | 13 | 138 | 0 | 1,022 |
| 2015 | 9 | 113 | 1 | 1,348 |
| 2016 | 0 | — | 3 | 1,379 |
| 2017 | 0 | — | 0 | 864 |
| 2018 | 0 | — | 1 | 657 |
| 2019 | 0 | — | 2 | 518 |
| 2020 | 0 | — | 0 | 796 |
| 2021 | 0 | — | 0 | 525 |
| 2022 | 0 | — | 2 | 335 |
| 2023 | 0 | — | 0 | 332 |
| 2024 | 0 | — | 0 | 436 |
| 2025 | 0 | — | 0 | 494 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Synthes Spine Occipital-Cervical Plate/Rod and Hook System is intended to provide stabilization to
promote fusion of the cervical spine and occipital-cervical junction (occiput — T3) for the following
indications:
. Degenerative disc disease of the cervical vertebrae (neck pain of discogenic origin with
degeneration of the disc as confirmed by patient history and radiographic studies)
o Spondylolisthesis of the cervical vertebrae
. Spinal stenosis of the cervical vertebrae
. Atlanto-axial fracture with instability
. Occipital-cervical dislocation
. Revision of cervical spine fusion surgeries
. Tumors
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K982322 · printed Nov 6, 2026
Cite this page
510(k) Report. “K982322: Synthes Spine Occipital-Cervical Plate/Rod and Hook System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K982322
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026